The effect of adherence to guidelines for initial antiretroviral therapy on 1-year outcomes: a French cohort study

Laurent Cotte 0 1 3 Thomas Bnet 2 7 Philippe Vanhems 2 7 Corinne Brochier 6 Thomas Perpoint 1 3 Tristan Ferry 1 3 4 5 Christian Chidiac 1 3 5 0 INSERM, U1052 , Lyon , France 1 Department of Infectious and Tropical Diseases, Hopital de la Croix-Rousse, Hospices Civils de Lyon , Lyon , France 2 Infection Control and Epidemiology Unit, Edouard Herriot Hospital , Hospices Civils de Lyon, Lyon , France 3 Department of Infectious and Tropical Diseases, Hopital de la Croix-Rousse, Hospices Civils de Lyon , Lyon , France 4 CIRI, INSERM U1111 , Lyon , France 5 University Claude Bernard - Lyon-1 , Lyon , France 6 Clinical Research Unit, Hopital de la Croix-Rousse, Hospices Civils de Lyon , Lyon , France 7 University Claude Bernard - Lyon-1, UMR CNRS 5558 , Lyon , France Background: Guidelines for antiretroviral treatment (cART) are published regularly, but there is little information regarding the effect of adherence to guidelines on patient outcomes. We assessed the effect of following the when-to-start and what-to-start guidelines, on treatment modifications, and on immunological and virological outcome at 12 months in a cohort of HIV-1 infected patients initiating cART from 2000 to 2010. Methods: Consecutive HIV-1 infected patients, antiretroviral naive, initiating cART from 2000 to 2010 at a University Hospital were enrolled. HIV-2 infection, cART for prevention of mother-to-child transmission or during primary HIV-infection and unlicensed drugs were excluded. The respect or not of the when-to-start and what-to-start guidelines was based on French guidelines published from 2000 to 2010. Factors associated with cART modifications at 12 months and factors associated with an HIV viral load of <50 copies/mL at 12 months were assessed by univariate and multivariate logistic regression modeling. Variations in CD4 counts from baseline were assessed by univariate and multivariate linear regression. Results: Of 1365 patients starting cART, 151 were treated outside when-to-start guidelines and 150 were treated outside what-to-start guidelines. Not using when-to-start guidelines was mainly related to early initiation in young men having sex with men, and was not associated with a significantly different outcome at 12 months. Treatments that did not follow what-to-start guidelines were not observed in any specific population and were associated with more treatment modifications and a poorer virological outcome at 12 months. Conclusions: Adherence to what-to-start guidelines is associated with a better outcome at 12 months in HIV-infected patients initiating antiretroviral therapy. Efforts should be made to promote adherence to these guidelines. - Background The introduction of combined antiretroviral therapy (cART) in 1996 led to a dramatic improvement in HIV disease prognosis, from a deadly disease to a manageable chronic infection compatible with a normal or nearnormal life expectancy [1-3]. Since then, several national or international scientific societies have published guidelines to help physicians decide the optimal time to start antiretroviral treatment (when-to-start guidelines) and the optimal antiretroviral combinations to use (what-to-start guidelines) [4-7]. Guidelines are updated regularly based on availability of new drugs and evidence from clinical trials. Most national and international consensus guidelines are broadly similar in their recommendations, particularly around what-to-start. Following the guidelines depends on the availability of the drugs and the organization of the health-care system, but also on physicians personal experience. For example, prescription of not recommended drugs may occur because of the guidelines lag behind clinical trial results but also in specific clinical situations such as HCV or HBV coinfections, renal insufficiency or treatment of opportunistic infections. The availability of numerous drugs facilitates the prescription of various combinations in industrialized countries, resulting in a significant proportion of prescriptions outside the recommendations [8]. Few studies have reported adherence to guidelines in industrialized countries [9-15]. Some of these studies included patients who started antiretroviral treatment before the cART era [10] or shortly after [11,12,14], a time when suboptimal treatments such as dual-nucleoside combinations were still prescribed. Most of these studies focused on adherence to guidelines and little information was available regarding the effect of adherence to guidelines on the outcome of cART [14]. We conducted an analysis of first line cART in a large cohort of patients who initiated cART from 2000 to 2010. We hypothesized that good adherence to guidelines would improve patients outcome, independent of the time period. One-year outcomes were studied according to whether or not the patients treatment followed the French national guidelines applicable during the time of treatment. Methods Study population and design The Department of (...truncated)